The following data is part of a premarket notification filed by In2bones Sas with the FDA for In2bones Kirschner Wire.
| Device ID | K153204 |
| 510k Number | K153204 |
| Device Name: | In2Bones Kirschner Wire |
| Classification | Pin, Fixation, Smooth |
| Applicant | IN2BONES SAS 28 CHEMIN DU PETIT BOIS Ecully, FR 69130 |
| Contact | Morgane Grenier |
| Correspondent | Norman F Estrin Estrin Consulting Group LLC 9109 Copenhaver Drive Potomac, MD 20854 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-04 |
| Decision Date | 2016-02-01 |
| Summary: | summary |